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Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479491
First Posted: November 24, 2011
Last Update Posted: October 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.

Condition Intervention
Intussusception Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of IS in subjects aged < 12 months [ Time Frame: Between January 2005 and April 2011 (6 years) ]
  • Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan [ Time Frame: Between January 2005 and April 2011 (6 years) ]

Secondary Outcome Measures:
  • Number of IS cases hospitalized more than once among subjects aged < 12 months. [ Time Frame: Between January 2005 and April 2011 (6 years) ]
  • Occurrence of IS cases by calendar months and year among subjects aged < 12 months [ Time Frame: Between January 2005 and April 2011 (6 years) ]

Enrollment: 54
Study Start Date: November 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Case Group
Children aged < 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB).
Other: Data collection
Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged <12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.
Criteria

Inclusion Criteria:

  • A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
  • An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479491


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01479491     History of Changes
Other Study ID Numbers: 116259
First Submitted: November 22, 2011
First Posted: November 24, 2011
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by GlaxoSmithKline:
Japan
Retrospective
Observational
Epidemiological study
Children aged < 12 months
Intussusception

Additional relevant MeSH terms:
Intussusception
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases